Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Intrinsic capacity
Study Overview
Brief Summary
The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults.
The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months.
Information will be collected by researchers at baseline, monthly and after study finishes.
Detailed Description
The aging process is associated with physiological changes that determine a decrease in functional reserve and limit the ability to respond to external factors.
Likewise, aging is associated with a deterioration of the regulatory processes that maintain the functional integration of the different organs and systems. A direct consequence of this phenomenon is the atypical presentation of highly prevalent diseases in the elderly. This atypical presentation of diseases in the elderly is responsible for the so-called geriatric syndromes, considered as specific nosological entities with a high frequency of presentation in the elderly, being included within the prevention, diagnosis and treatment strategies of geriatric medicine.
These syndromes can generate greater morbidity and consequences, sometimes more serious than the disease that produces them. Its systematic detection should be included in the anamnesis of the clinical history of the elderly. Geriatric syndromes are a group of conditions usually caused by the conjunction of diseases with a high prevalence in the elderly and which are the frequent origin of functional or social disability in the population. They are the manifestation of many diseases, but they are also the beginning of many other problems that we must take into account from their detection to establish a good prevention of them.
The hypothesis of this work is that in frail and pre-frail older adults who participate in an integrated program of multicomponent physical exercise tutored by means of an app will improve their functional situation and reverse their diagnoses of pre and frailty.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Cohort study no masking presented.
Eligibility Criteria
- Ages
- 65 Years to 100 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Informed consent signature
Exclusion Criteria
- •Life expectancy less than 6 months
- •Acute Ischemic coronariopathy event during the last three months
- •Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
- •Major surgery during the last six months
Arms & Interventions
Intervention
Multicomponent exercise program twice a week (2 hours per week) during six months
Intervention: Multicomponent exercise program (Behavioral)
Control Goup
Usual routine.
Outcomes
Primary Outcomes
Intrinsic capacity
Time Frame: Six months
ICOPE questionnaire score
Frailty reversion.
Time Frame: Six months
Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail
Quality of life objective and subjective
Time Frame: Six months
EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.
Polypharmacy
Time Frame: Six months
Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.
Cognitive state
Time Frame: Six months
Pfeiffer questionnaire
Nutrition state
Time Frame: Six months
Mini Nutritional Assessment Short Form. Score 0 to 14.
Falls
Time Frame: Six months
Number of falls during follow-up period
Depression
Time Frame: Six months
Yesavage's Geriatrics Depression Scale (15 items)
Sarcopenia
Time Frame: Six months
European Working Group on Sarcopenia in Older People (EWGSOP) criteria
Secondary Outcomes
- Validation of a gait speed mobile phone tool(Six months)
- Validation of a shaking measurement tool to asses muscle strength(six months)
- Hospital admissions(Six months)
- Visits to General Practitioner (GP)(Six months)
- Validation of a pulmonar capacity mobile phone tool(six months)
Investigators
Francisco Jose Tarazona-Santabalbina
MD, Ph D
Hospital de la Ribera
